Vol.55 No.S-1 October 2007
Clinical phase III open-labeled study of oral garenoxacin in patients with respiratory tract infection by penicillin-resistant Streptococcus pneumoniae
1)Division of Molecular and Clinical Microbiology, Department of Molecular Microbiology and Immunology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, Japan
2)Department for Respiratory Medicine, Division of Cancer Control, Institute of Development, Aging and Cancer, Tohoku University
(Present: Research Division for Development of Anti-Infective Agents, Institute of Development, Aging and Cancer, Tohoku University)
3)Department of Internal Medicine, Shinrakuen Hospital
4)Department of Microbiology and Infectious Diseases, Toho University School of Medicine
5)Department of Respiratory Medicine and Allergy, Tosei General Hospital
6)Division of Respiratory Diseases, Department of Internal Medicine, Kawasaki Medical School Hospital
(Present: Division of Clinical Infectious Diseases, Showa University School of Medicine)
7)Department of Cardiology, Graduate School of Medicine and Faculty of Medicine, University of Tokyo
Abstract
The efficacy and safety of garenoxacin mesilate hydrate(GRNX), a novel oral des-fluoroquinolone, were evaluated in patients with respiratory tract infection caused by penicillin-intermediate resistant S.pneumoniae(PISP) and penicillin-resistant S. pneumoniae(PRSP).
1. Clinical efficacy: The efficacy rates at the end of treatment in patients caused by PISP, PRSP, and penicillin-susceptible S. pneumoniae(PSSP) pathogens were 8/9, 93.8% (15/16) and 100% (22/22). The efficacy rate in patients with resistance-unknown S. pneumoniae was 4/4, and the total efficacy rate was 96.1% (49/51). The efficacy rates at 3 days after treatment in total, PRSP, PISP, PSSP and resistance-unknown strains were 84.3% (43/51), 8/9, 75.0% (12/16) and 4/4.
2. Bacteriological efficacy: The eradication rates at 3 days after treatment or at the end of treatment in total, PRSP, PISP, PSSP and resistance-unknown strains were 100% (50/50), 9/9, 100% (16/16), 100% (21/21) and 4/4.
3. Safety: Incidence of adverse events and laboratory abnormalities were 8.1% (8/99) and 30.3% (30/99). No strange event was observed. No clinically relevant electrocardiogram abnormalities mere noted.
Results suggest that 400 mg daily treatment of GRNX administered is useful for patients with respiratory tract infection including patients caused by penicillin-resistant S. pneumoniae.
Key word
garenoxacin, penicillin-resistant Streptococcus pneumoniae
Received
June 8, 2007
Accepted
August 6, 2007
Jpn. J. Chemother. 55 (S-1): 185-193, 2007
